The present invention relates to methods and compositions for the treatment of neurological, behavioral and/or immunological disorders and more particularly, to a new medical use for the natural or synthetic hormone secretin in the treatment of autism and other neurological, behavioral and/or immunological disorders.
Autism is a disabling neurological disorder that affects thousands of Americans and encompasses a number of subtypes, with various putative causes and few documented ameliorative treatments. The disorders of the autistic spectrum may be present at birth, or may have later onset, for example, at ages two or three. There are no clear cut biological markers for autism. Diagnosis of the disorder is made by considering the degree to which the child matches the behavioral syndrome, which is characterized by poor communicative abilities, peculiarities in social and cognitive capacities, and maladaptive behavioral patterns.
A number of different treatments for autism have been developed. Many of the treatments, however, address the symptoms of the disease, rather than the causes. For example, therapies ranging from psychoanalysis to psychopharmacology have been employed in the treatment of autism. Although some clinical symptoms may be lessened by these treatments, modest improvement, at best, has been demonstrated in a minor fraction of the cases. Only a small percentage of autistic persons become able to function as self-sufficient adults.
Although much controversy exists about the causes and treatments of autism, a few established biomedical findings have been made. Many individuals with autism experience intestinal difficulties, often including the inability to digest gluten and casein. Abnormalities have also been found in the metabolism of the neurotransmitter serotonin and in various parameters of immune system functions, for example, elevated Measles, Mumps and Rubella. (MMR) titers. Prior to the discovery of the present invention, however, no useful links had been made between these biomedical findings, nor had any Success treatments been derived therefrom, as disclosed in various articles incorporated herein by reference.1 
1 Priven, J. (1997). The biological basis of autism. Current Opinion in Neurobiology, 7, 708-712. 
Rapin, L. and Katzman, R. (1998). Neurobiology of autism. Ann Neurology, 43, 7-14. 
Similar to autistic spectrum disorder, many other behavioral, neurological and immunological disorders have been equally difficult to understand and to effectively treat. Such disorders include depression, obsessive-compulsive disorder, Alzheimer""s, allergies, anorexia, schizophrenia, as well as other neurological conditions resulting from improper modulation of neurotransmitter levels or improper modulation of immune system functions, as well as behavioral disorders such as ADD (Attention Deficit Disorder) and ADHD (Attention Deficit Hyperactivity Disorder), for example. Accordingly, a need exists for a method and composition for the treatment of autism and other behavioral, neurological and/or immunological disorders.
The hormone secretin is a polypeptide hormone secreted by the mucosa of the duodenum and upper jejunum when acid chyme enters the intestine. The hormone secretin stimulates the pancreatic acinar cells to release bicarbonate and water, which are excreted into the duodenum and change the pH in the gut from acid to alkaline, thereby facilitating the action of digestive enzymes. Secretin is always used and indeed is intended only to be used in diagnostic tests given to patients with gastrointestinal disorders to stimulate the release of pancreatic juices for testing purposes.
Prior to the discorvery of the present invention however secretin has never before been linked to autistic spectrum disorders, either as a possible cause or treatment, nor has it been used in the treatment of other neurological and/or
Wing, L. (1997). The autistic spectrum. The Lancet, 350 (December 13), 1761-1765. immunological disorders, as herein proposed. 
The present invention features a method for the treatment of neurological, immunological and other disorders in a patient. The method comprises the step of stimulating the secretion of pancreatic juices in the patient. In one embodiment, stimulating the secretion of pancreatic juices comprises the step of administering to the patient an effective amount of natural or synthetic secretin. The preferred method of the present invention is for the treatment of autistic spectrum disorder.
According to one method of administering secretin, the secretin is administered by infusion and the effective amount is generally 2 clinical units (CU) per kilogram (kg) of body weight given intravenously within 1 minute. In another method, the secretin is administered transdermally by applying a transdermal carrier substance, such as dimethyl sulfoxide (DMSO) to the skin, applying crystalline secretin in an effective amount onto the carrier substance, and rubbing the composition into the skin. One example of an effective amount of secretin administered transdermally includes about 15 CU of crystalline secretin.
Other methods of administering secretin include, but are not limited to, administering secretin transdermally with a gel, lotion or patch; administering secretin with a suppository; administrating secretin orally, as tablet, capsule or lozenge; administrating secretin by inhalation (e.g., as an aerosol) either through the mouth or the nose; and administering secretin using acoustic waves to permeate the skin. The present invention also contemplates other physiologically acceptable carriers or excipients for carrying an effective amount of secretin into the patient""s body.
In another embodiment, the method for stimulating the secretion of pancreatic juices comprises the step of causing the body to secrete secretin in an effective amount to at least ameliorate and preferably treat autism and other neurological and/or immunological disorders. This method includes, for example, stimulating or otherwise causing the duodenum and upper jejunum to secrete the hormone secretin for one or more of the purposes described herein.
The present invention also features compositions for use according to the above methods. In one embodiment, a pharmaceutical composition, according to the present invention includes an effective amount of secretin together with a suitable volume of sodium chloride for dissolving the secretin and carrying the secretin into the body by infusion. In another embodiment, a composition according to the present invention includes an effective amount of secretin and a transdermal carrier substance, such as DMSO for carrying the secretin into the body transdermally. Other compositions include an effective amount of secretin together with physiologically acceptable carriers or excipients for carrying the secretin into the patient""s body. The present invention contemplates the use of both natural and synthetically produced secretin.